- Members of an FDA orthopaedic devices advisory panel this week recommended the down-classification of noninvasive bone growth stimulators (BGS) from Class III to Class II, effectively endorsing the agency's pitch in August to do so. Although the recommendation encourages removing the requirement for new devices to come to market via more rigorous premarket approval (PMA) submissions, panelists supported still requiring more robust clinical evidence, the parameters for which are yet to be defined.
- Manufacturers of the devices, including Orthofix, Zimmer Biomet and Bioventus, supported maintaining the PMA standard, but seemed receptive to discussion of imposing high clinical standards on potential Class II entrants.
- The comment period for FDA's proposal remains open until Oct. 16. A bipartisan group of congressmen submitted a letter ahead of the meeting chastising the agency for proposing the down-classing prior to hearing the expert panel's recommendations.
While the orthopaedic devices panel was also tasked with considering appropriate categorization for some pre-amendment devices (facet screws, intra-abdominal pressure monitoring devices, intracompartmental pressure monitor devices, and cemented total first metatarsophalangeal replacement devices), the most sizable agenda item was FDA potentially changing how it regulates bone growth stimulators — a U.S. market that is worth about $500 million, according to analysts at Jefferies.
Historically, market entrants have faced the costly PMA standard. Even with the imposition of special controls that require premarket clinical data and postmarket surveillance, if FDA finalizes the transition to Class II, devices could come to market via the lower-barrier 510(k) pathway.
A Zimmer Biomet spokesperson said in an email following the panel's agreement with FDA to down-class the devices that the company believes, "the current Class III PMA process is effective and appropriate for bone growth stimulation products to ensure patient safety and therapy efficacy. We will continue to provide our input regarding the proposal during the FDA's public comment period."
A Bioventus spokesperson said that while the company's preference is to maintain its bones healing system as a Class III device, "if bone stimulators are reclassified into Class II, we see that decision as neutral to our business."
"Any new competitor will not only need clinical data to enter the market, it will also need it to be data of significance to gain the confidence of payers," the spokesperson added.
Likewise, Orthofix CEO Jon Serbousek said following the meeting the company "will be submitting comments in response to the FDA's proposed rulemaking to underscore the Advisory Panel's recommendation of the need for robust clinical data prior to approval or clearance of bone growth stimulator products, together with postmarket surveillance requirements."
Jefferies analysts wrote the "outcome of the panel meeting holds significant implications" for Orthofix, citing that BGS products accounted for 43% of the company's sales last year.
Still, risk isn't likely to be near term. "While there is a risk that pricing could fall, it isn't going to be immediate and the path for any new entrant will be long," the analysts said.
FDA officially proposed the reclassification in August, opening a 60-day comment period. A bipartisan group of congressmen — Reps. Mike Levin, D-Calif., Jim Banks, R-Ind., Larry Buschon, R-Ind., and Steve Cohen, D-Tenn. — said in a letter posted to the FDA docket Thursday the agency should not have issued a reclassification proposal until after the panel.
"In all likelihood, upon review of all relevant evidence, testimony, and public comment, FDA's expert panel will again conclude that BGS devices are appropriately classified in Class III," the lawmakers incorrectly predicted. "However, we are concerned that FDA has already prejudged the outcome to the contrary."